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High performance liquid chromatographic analysis of dehydroepiandrosterone and its pharmaceutical tablet formulation
Author(s) -
AboulEnein Hassan Y.
Publication year - 2004
Publication title -
biomedical chromatography
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.4
H-Index - 65
eISSN - 1099-0801
pISSN - 0269-3879
DOI - 10.1002/bmc.284
Subject(s) - chemistry , chromatography , acetic acid , calibration curve , methanol , high performance liquid chromatography , detection limit , sodium acetate , pharmaceutical formulation , quantitative analysis (chemistry) , organic chemistry
A rapid, sensitive and stability indicating high performance liquid chromatographic method was developed and validated for the analysis of dehydroepiandrosterone (DHEA) in pharmaceutical tablet formulation. The analysis was done on a Supelcosil C 18 column (25 cm × 4.6 mm i.d., 5 µm). The mobile phase consisted of methanol:sodium acetate buffer solution (5 g/L):acetic acid (500 mL/L), 57:42:1, v/v/v, adjusted to pH 5 at a ow rate of 1 mL/min. Detection was carried out at a wavelength of 258 nm. The polynomial regression data for the calibration curve showed good linear relationship in the concentration range of 0.2–1 mg/mL with r = 0.9996. The method was validated for precision, accuracy and recovery. The limit of detection was found to be 50 ng/µL. The method was applied for the analysis of DHEA in its pharmaceutical tablet formulation. The effects of different buffers and alcohols on the retention of DHEA were studied and the role of acetic acid as an organic phase modier was also investigated. Copyright © 2003 John Wiley & Sons, Ltd.